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ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mL Cream — NDC 84610-0200-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mL Cream — NDC 84610-200-01 (Billing 84610-0200-01)

by The Founders Inc. · 1 TUBE in 1 CARTON / 50 mL in 1 TUBE

This is a package of ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mL Cream from The Founders Inc., marketed since Apr 2025 and currently FDA-listed. It is this product's only package size.

NDC 84610-0200-01
🏷️ FDA NDC (as labeled) 84610-200-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 84610-200-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84610 labeler · 200 product · 01 package
Package marketed since
Apr 30, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8461020001 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84610-200-01
Product NDC 84610-200
11-digit billing NDC 84610020001
UNII G63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM
Application # M020
SPL Set ID 31af7b5e-2bd6-63ee-e063-6294a90a0806
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-30
Route TOPICAL
Dosage form CREAM
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 84610-200-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84610-0200-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is a topical sunscreen cream marketed as an OTC monograph product. It contains four active ingredients that function as UV filters: avobenzone, homosalate, octisalate, and octocrylene. These ingredients are typically used together in sunscreen formulations to absorb and scatter ultraviolet radiation from the sun. The product is applied to the skin to help protect against sun exposure.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
84610-0200-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 50 mL in 1 TUBE 2025-04-30 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anua Zero-Cast Moisturizing Finish Sunscreen SPF 50 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mL 14268-0169-50 ENGLEWOOD 50 ml — — FDA listed —
Anua Zero-Cast Moisturizing Finish Sunscreen 30 mg/mL; 70 mg/mL; 50 mg/mL; 50 mg/mLthis 84610-0200-01 The 1 tube — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII F01RIY4371
    A synthetic polymer made from acrylic compounds and taurate, this substance acts as a thickener and stabilizer. It helps give liquid medicines a smooth texture and keeps ingredients from separating.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII 255PIF62MS
    A synthetic antioxidant compound used to prevent oils and fats in medications from breaking down or becoming rancid during storage. It helps maintain the medicine's stability and shelf life.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 65A9F4P024
    A synthetic compound derived from the amino acid glutamate and stearic acid. It acts as an emulsifier and surfactant to help mix oil and water-based ingredients, keeping the medicine uniform throughout.
  • UNII 035MV9S1C3
    A plastic-like polymer made from two chemical compounds joined together. It acts as a binder and film-former in tablets and capsules, helping hold ingredients together and create a protective coating on the medicine's surface.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

17 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesWater (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Niacinamide, Sodium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydroxyacetophenone, Phenoxyethanol, Tocopheryl Acetate, Panthenol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexanediol, Sodium Hyaluronate

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerThe Founders Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code84610
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio3 products on file

More NDCs from The Founders Inc. labeler code 84610

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📋 Description 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures(see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

⏱️ Dosage and Administration 106 words ▾

Directions For sunscreen use: ■ Apply liberally 15 minutes before sun exposure ■ Reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ Children under 6 months of age: Ask a doctor ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.- 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses

⚠️ Warnings 57 words ▾

Warnings For external use only Do not use ■ on damaged or broken skin When using this product ■ keep out of eyes. Rinse with water to remove Stop use and ask a doctor if ■ rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Avobenzone 3.0% Homosalate 7.0% Octisalate 5.0% Octocrylene 5.0%

🧪 Inactive Ingredients 36 words ▾

Inactive ingredients Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Niacinamide, Sodium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydroxyacetophenone, Phenoxyethanol, Tocopheryl Acetate, Panthenol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexanediol, Sodium Hyaluronate

🎯 Purpose 2 words ▾

Purpose Sunscreen

📋 Description ~1 min read ▾

Drug Facts Active Ingredients Avobenzone 3.0% Homosalate 7.0% Octisalate 5.0% Octocrylene 5.0% Purpose Sunscreen Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures(see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun Warnings For external use only Do not use ■ on damaged or broken skin When using this product ■ keep out of eyes. Rinse with water to remove Stop use and ask a doctor if ■ rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions For sunscreen use: ■ Apply liberally 15 minutes before sun exposure ■ Reapply: ■ after 80 minutes of swimming or sweating ■ immediately after towel drying ■ at least every 2 hours ■ Children under 6 months of age: Ask a doctor ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m.- 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses Other information ■ Protect the product in this container from excessive heat and direct sun Inactive ingredients Water (Aqua), Butyloctyl Salicylate, Glycerin, Dimethicone, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Cetearyl Alcohol, Niacinamide, Sodium Stearoyl Glutamate, Ammonium Polyacryloyldimethyl Taurate, Hydroxyacetophenone, Phenoxyethanol, Tocopheryl Acetate, Panthenol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxyhydrocinnamate, Xanthan Gum, 1,2-Hexanediol, Sodium Hyaluronate Questions? +1-888-899-9083 Monday–Friday (9 a.m.–5 p.m.

EST) www.anua.us

📄 Do Not Use 9 words ▾

Do not use ■ on damaged or broken skin

📄 When Using This Product 14 words ▾

When using this product ■ keep out of eyes. Rinse with water to remove

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if ■ rash occurs

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 15 words ▾

Other information ■ Protect the product in this container from excessive heat and direct sun

📄 Questions or Comments 8 words ▾

Questions? +1-888-899-9083 Monday–Friday (9 a.m.–5 p.m. EST) www.anua.us

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL 1 KDH Package

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for ANUA ZERO-CAST MOISTURIZING FINISH SUNSCREEN (this brand).

Top reported reactions

Acute Myeloid Leukaemia2
Exposure To Toxic Agent2
Product Contamination Chemical2
Rash2
Anaphylactic Reaction1
Application Site Erythema1
Application Site Exfoliation1

Age at onset

Adolescent2
Adult1

Reporter sex

6 reports
Male · 20%
Female · 80%

Serious outcomes

Hospitalization2
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 2 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by The Founders Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
The Founders Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 84608-0651-06 · DOSCHER 84610-0300-01 · The →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.